Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

Study hypothesis

Traumatic spinal cord injury (SCI) is rare but has devastating consequences on the quality of life of patients and their families. Figures from the UK are difficult to obtain, but we estimate that 100,000 patients in England receive spinal immobilisation each year. As modern trauma care appropriately assumes that injury is present until excluded, this creates a huge demand for effective spinal immobilisation.

Current methods usually involve a semi-rigid collar with head blocks and tape, but we and others have shown that this does not adequately immobilise the neck, allowing movement of the spine risking further injury. The rigid collar prevents opening of the mouth leading to feelings of claustrophobia, and potential danger of inhaling vomit. If the patient stops breathing, the collar must be removed to enable insertion of a breathing tube, increasing the risk of spinal cord damage. Pressure of the collar on the back of the head can cause pressure sores, and on the root of the neck can increase pressure within the brain, worsening any existing head injury.

We have invented a device providing better immobilisation without preventing mouth opening, leading to a safer experience. It can be applied before the patient is removed from a vehicle increasing safety for patient and paramedic, and can be left on during X-rays and other investigations.

We will train paramedics to use the device and ask volunteers to compare it to current methods by measuring movement of the spine, ability to open the mouth for normal breathing, ability to intubate, measuring risk of pressure sores, and conducting interviews and observations to gather the experience of volunteers and paramedics. Following feedback we will redesign and retest the device, and perform MR scanning that uses magnetic fields and a computer to measure movement between individual neck bones. We believe we have a device that is effective, more comfortable and safer for patients and easier for paramedics to use.

Ethics approval

West Midlands - South, 31/05/2012, ref: 12/WM0098

Study design

Non-randomised observational qualitative study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Injuries and Emergencies, Anaesthetics

Intervention

We are testing two versions of the prototype device on healthy volunteers to measure the degree of immobilisation of the head in relation to the shoulders, and the spinal cord, compared to two currently-used devices. We are obtaining the opinions of paramedics trained to apply the device on how it can be improved, and how it compares to their normal experience of applying spinal immobilisation. We are obtaining the opinion of anaesthetists on ease of intubation of a manikin wearing the new and comparator devices.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Prototype testing

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/07/2012

Overall trial end date

31/05/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy volunteers employed by the ambulance service or medical school, or training as a medical student and a willingness to take part in the study2. Male and female participants 3. Aged 18 - 60 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 140

Participant exclusion criteria

1. For the first prototype testing we shall exclude people who have known neck problem or history of neck surgery, injury to the neck within the previous 12 months2. Any condition resulting in restriction of neck movement, known claustrophobia, and, for the second prototype testing involving MR scanning 3. People with metallic implants, pacemaker4. People who are, or may be, pregnant5. Refusal to sign the confidentiality agreement will be an exclusion criterion